Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT01280591 | Completed Phase 3 Results

• 1 other identifier: 14837
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.

Conditions

Pain, Postoperative

Keywords

Naproxen sodium; Diphenhydramine

Outcome Measures

Primary Outcomes (2)

• Wake Time After Sleep Onset (WASO) Measured by Actigraphy

  WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

  Up to 10 hours

• Sleep Latency Measured by Actigraphy

  Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

  Up to 10 hours

Secondary Outcomes (19)

• Total Sleep Time Measured by Actigraphy

  Up to 10 hours

• Sleep Efficiency Measured by Actigraphy

  Up to 10 hours

• Global Assessment of Investigational Product as a Sleep Aid

  Up to 10 hours

• Karolinska Sleep Diary - Sleep Quality

  Up to 10 hours

• Karolinska Sleep Diary - Calmness of Sleep

  Up to 10 hours

Study Arms (4)

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

EXPERIMENTAL

Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

EXPERIMENTAL

Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 440 mg (BAYH6689)

ACTIVE COMPARATOR

Drug: Naproxen sodium 440 mg (BAYH6689)

DPH 50 mg

ACTIVE COMPARATOR

Drug: DPH 50 mg

Interventions

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) DRUG

Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) DRUG

Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 440 mg (BAYH6689) DRUG

Participants received two Naproxen sodium 220 mg tablets orally, single dose

Naproxen sodium 440 mg (BAYH6689)

DPH 50 mg DRUG

Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

DPH 50 mg

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, ambulatory, male and female volunteers ages 12 and older
• Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
• one full bony impaction
• two partial bony impactions
• one full bony impaction and one partial bony impaction
• one full bony impaction and one soft tissue impaction
• one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
• Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of ≥ 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \<18 years of age must sign a written assent and have parental or guardian consent).

You may not qualify if:

• History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products
• Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
• Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
• Current or past history of bleeding disorder(s)
• Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
• Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
• Positive alcohol breathalyzer test and positive urine drug test prior to surgery
• Females who are pregnant or lactating
• Chronic or severe sleep problems that do not respond to / Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
• Habitually spends less than 6.5 hours in bed

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Austin, Texas, 78744, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.

  PMID: 25996289 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 8, 2015
• Results First Posted: June 17, 2014

Record last verified: 2015-05

Locations

US (2)